FDA 510(k) Application Details - K013714

Device Classification Name Set, Administration, Intravascular

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510(K) Number K013714
Device Name Set, Administration, Intravascular
Applicant CODAN US CORP.
3511 WEST SUNFLOWER AVE.
SANTA ANA, CA 92704-6944 US
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Contact MARILYN R POURAZAR
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Regulation Number 880.5440

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Classification Product Code FPA
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Date Received 11/08/2001
Decision Date 03/28/2002
Decision SESE - SUBST EQUIV
Classification Advisory Committee HO - General Hospital
Review Advisory Committee HO - General Hospital
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party N
Expedited Review



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